At BCOPharma and affliate Brepco Biopharma, we believe that there are many instances where pediatric diseases are poorly treated because physicians have to rely on drug therapies that were developed with an adult population as a first priority.

Brepco’s lead product—Neoatricon— is a proprietary, age-appropriate (and therefore safer) formulation of dopamine that is used to treat hypotension in critically ill babies and children.

The company has filed for a Paediatric Use Marketing Authorization with the European Medicines Agency for Neoatricon and hope for an approval in mid-to late-2023. Because it is PUMA-eligible, if approved, the product will have 10 years market and data exclusivity within the EU.

About 200,000 paediatric patients, mostly newborn babies and infants, are treated for hypotension in the US and Europe each year. The conditions associated with hypotension are typically life-threatening and patients often require urgent treatment. Dopamine is the first-line drug intervention for approximately 80% of these patients. However, it is not approved for use in paediatric patients, nor is it supplied in a dosage form suitable for children and babies. Because it is an age-appropriate formulation, Neoatricon will be safer to administer to babies and children than the current adult-only approved product.

As part of the product’s development program Brepco, along with a consortium of EU and Canadian hospitals led by Cork University Hospital, conducted a clinical trial in babies born at less than 28 weeks gestational age to better understand how hypotension in this vulnerable population should be treated.

Despite being approved only for adult use; dopamine is commonly used in paediatric and neonatal medicine. Dopamine has been listed on the World Health Organization List of Essential Medicines for Children and was granted an Orphan Designation for the prevention of non-traumatic intraventricular hemorrhage but the US Food and Drug Administration.

Hypotension in premature babies: Survival of infants born prematurely has increased significantly over the last three decades, especially amongst the smallest and most immature babies. The improved survival rate has brought the increased challenge of treating conditions that are unique to very premature babies. Hypotension is one such condition that commonly impacts premature babies and can lead to an (non-traumatic) intraventricular hemorrhage (IVH) which may lead to death or neurodevelopmental disability.